EUCTR2018-000746-19-ES进行中（未招募）1 期
An open-label, single-arm, multi-centre, long-term extension trial to evaluate the safety and efficacy of tralokinumab in subjects with atopic dermatitis who participated in previous tralokinumab clinical trials - ECZTEND
EO Pharma A/S0 个研究点目标入组 1,125 人开始时间: 2018年8月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-Completed the treatment period(s) of one of the parent trials: LP0162-1325, -1326, -1339, -1341 or -1342.
- •-Complied with the clinical trial protocol in the parent trial to the satisfaction of the investigator.
- •-Able and willing to self-administer tralokinumab treatment (or have it administered by a caregiver) at home after the initial 3 injection visits at the trial site (in this trial).
- •-Stable dose of emollient twice daily (or more, as needed) for at least 14 days before baseline.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1105
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •-Any condition that required permanent discontinuation of trial treatment in the parent trial.
- •-More than 20 weeks have elapsed since the subject received the last injection of investigational medicinal product (IMP) in the parent trial
- •(to be assessed at baseline).
- •-Subjects who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to tralokinumab by the
- •investigator, which in the opinion of the investigator could indicate that continued treatment with tralokinumab may present an unreasonable
- •safety risk for the subject.
- •-Subjects who, during their participation in the parent trial, developed an AE that was deemed related to tralokinumab by the investigator and
- •led to temporary discontinuation of trial treatment, which in the opinion of the investigator could indicate that continued treatment with
- •tralokinumab may present an unreasonable safety risk for the subject.
- •-Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroid within 4 weeks prior to baseline.
- •-Treatment with topical phosphodiesterase 4 inhibitors within 2 weeks prior to baseline.
- •-Receipt of any marketed biological therapy (that is, immunoglobulin or anti-immunoglobulin E) including dupilumab or investigational
- •biologic agents:
- •o Any cell-depleting agents, including but not limited to rituximab: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer.
- •o Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline.
- •-Clinically significant infection within 4 weeks prior to baseline.
- •-A helminth parasitic infection within 6 months prior to the date when informed consent is obtained.
- •-Tuberculosis requiring treatment within 12 months prior to screening.
- •- Known primary immunodeficiency disorder.
研究者
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